Bioavailability of ABT-450 and ABT-267 With Ritonavir

A Phase I, Open-Label, Single Centre Study Designed to Determine the Absolute Bioavailability of ABT-450 (150 mg) and ABT-267 (25 mg) When Administered as an Oral Co-Formulated Product With Ritonavir (100 mg), ABT 450/r/ABT 267, to Healthy Adult Subjects

A study to investigate the fraction of ABT-267 and ABT-450 absorbed by the body when given in combination with each other and Ritonavir(r).

Study Overview

• Status: Completed
• Conditions: Absolute Bioavailability
• Intervention / Treatment: Drug: ABT-450/r/ABT-267

Detailed Description

Absolute bioavailability of ABT-267 and ABT-450 in the body when given together

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • Nottingham, United Kingdom, NG11 6JS
    • Site Reference ID/Investigator# 118615

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Healthy males or non-pregnant, non-lactating healthy females
2. Body mass index of 18.0 to 30.0 kg/m2
3. Must be willing and able to communicate and participate in the whole study
4. Must provide written informed consent
5. Must agree to use an adequate method of contraception
6. In a condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile and a 12-lead ECG

Exclusion Criteria:

1. Participation in a clinical research study within the previous 3 months or in an absorption, distribution, metabolism, and excretion (ADME) study within the previous 12 months
2. History of any drug or alcohol abuse in the past 2 years or current smokers and those who have smoked within the last 12 months or a positive cotinine urine test at screening and admission
3. Radiation exposure, including that from the present study, excluding background radiation but including diagnostic x-rays and other medical exposures, exceeding 5 mSv in the last 12 months or 10 mSv in the last 5 years. No occupationally exposed worker, as defined in the Ionising Radiation Regulations 1999, shall participate in the study
4. Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) results
5. Donation or loss of greater than 550 mL of blood (including plasmapheresis) or receipt of a transfusion of any blood product within the previous 8 weeks
6. Subjects who are taking, or have taken, any prescribed or over-the-counter drug or herbal remedies within the 14 days or any drug by injection (including vaccines) within 30 days or within 10 half-lives of the respective medication, whichever is longer, before Investigational Medical Product (IMP) administration

Study Plan

How is the study designed?

Design Details

• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1 - Regimen A; 8 Subjects in Group I - Regimen A: ABT-450/r/ABT-267	Drug: ABT-450/r/ABT-267; ABT-450, ABT-267 and ritonavir
Experimental: Group 2 - Regimen B; 8 Subjects in Group II - Regimen B: ABT-450/r/ABT-267	Drug: ABT-450/r/ABT-267; ABT-450, ABT-267 and ritonavir

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Absolute bioavailability	dose normalized AUC(0-inf) for oral dose/dose normalized AUC(0-inf) for IV dose	Day 1 until 72 hours after single dose of ABT-450/r/ABT-267

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety Labs	Chemistry, Haematology, Urinalysis	Day -1 until 72 hours after single dose of ABT-450/r/ABT-267
Electrocardiograms (ECGs)	The measure of any change in 12 lead electrocardiogram from Day-1	Day-1 until 24 hours after single dose of ABT-450/r/ABT-267
Number of participants with adverse events		Screening until 7 days after single dose of ABT-450/r/ABT-267
Physical Exam	To examine any change from Day-1 in the subject's physical presentation (body temperature, blood pressure, pulse)	Day-1 until 72 hours after single dose ABT-450/r/ABT-267

Collaborators and Investigators

• Sponsor: AbbVie

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Actual): February 1, 2014
• Study Completion (Actual): February 1, 2014

Study Registration Dates

• First Submitted: January 30, 2014
• First Submitted That Met QC Criteria: January 30, 2014
• First Posted (Estimate): February 3, 2014

Study Record Updates

• Last Update Posted (Estimate): February 19, 2014
• Last Update Submitted That Met QC Criteria: February 17, 2014
• Last Verified: February 1, 2014

More Information

Terms related to this study

• Keywords: healthy volunteers; absolute bioavailability
• Other Study ID Numbers: M14-229; 2013-003685-14 (EudraCT Number)